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  • Yuhan¡¯s anticancer drug Leclaza secures European approval
  • by Cha, Jihyun | translator Alice Kang | Jan 2, 2025 06:10am
Will receive KRW 44.2 billion in milestone payments
First homegrown anticancer drug to receive approval in the US and Europe
As lung cancer has the highest mortality rate, the company expects sales royalties upon European launch
Additional milestones can be received upon Asian approval in Japan, China, etc.
 ¡ã Pic of Yuhan Corp
Yuhan Corp¡¯s new anti-cancer drug Leclaza (Lazertinib) has crossed the European threshold. The European Commission (EC) approved the drug a month after receiving a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). As a result, the company will receive a USD 30 million European launch milestone.

According to industry sources on the 31st, the EC granted final marketing authorization to the combination of Yuhan Corp¡¯s non-small cell lung cancer drug Leclaza and Johnson & Johnson's Rybrevant (amivantamab) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed epidermal growth
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